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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Lunan Pharmaceutical

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01 7-Aminodesacetoxycephalosporanic Acid (1)

02 Abiraterone Acetate (1)

03 Aceclofenac (1)

04 Acipimox (1)

05 Afatinib (1)

06 Alfuzosin HCl (1)

07 Apixaban (1)

08 Argatroban (1)

09 Atorvastatin (1)

10 Azilsartan (1)

11 Bortezomib (1)

12 Capecitabine (1)

13 Carfilzomib (1)

14 Cefditoren Pivoxil (1)

15 Clavulanic Acid (4)

16 Cyclobenzaprine (1)

17 Daptomycin (1)

18 Dasatinib (1)

19 Daunorubicin (1)

20 Daunorubicin HCl (1)

21 Decitabine (1)

22 Elagolix Sodium (1)

23 Enoxaparin Sodium (1)

24 Entecavir (1)

25 Epirubicin Hydrochloride (2)

26 Esomeprazole Sodium (1)

27 Etodolac (1)

28 Ezetimibe (1)

29 Faropenem (1)

30 Fasudil (1)

31 Fludarabine Phosphate (1)

32 Fosaprepitant (1)

33 Gefitinib (1)

34 Gimeracil (1)

35 Histamine Dihydrochloride (1)

36 Ibuprofen (1)

37 Imatinib Mesylate (1)

38 Isoflurane (2)

39 Isosorbide (1)

40 Isosorbide Dinitrate (1)

41 Isosorbide Mononitrate (4)

42 Ivabradine Hydrochloride (1)

43 Ketorolac Trometamol (2)

44 Levoamlodipine (1)

45 Miglitol (1)

46 Milrinone (1)

47 Montelukast Sodium (1)

48 Mosapride Citrate (1)

49 Mycophenolate Mofetil (1)

50 Mycophenolic Acid (1)

51 Orlistat (1)

52 Oteracil Potassium (1)

53 Palbociclib (1)

54 Pemetrexed Disodium (1)

55 Ramipril (1)

56 Rivaroxaban (1)

57 Rosuvastatin Calcium (1)

58 Salmeterol Xinafoate (1)

59 Sevoflurane (2)

60 Sirolimus (2)

61 Sitagliptin Phosphate (1)

62 Sodium Monosialotetrahexosylganglioside (1)

63 Tacrolimus (2)

64 Tadalafil (1)

65 Tegafur (1)

66 Tenofovir Disoproxil Fumarate (1)

67 Tolterodine Tartrate (1)

68 Zanamivir (1)

69 Zoledronic Acid (2)

70 Zolpidem Tartrate (2)

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01 Active (35)

02 Inactive (7)

03 Blank (42)

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01 Valid (8)

02 Withdrawn by Holder (1)

03 Blank (75)

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01 223MF10040 (1)

02 228MF10006 (1)

03 303MF10148 (1)

04 304MF10119 (1)

05 304MF10137 (1)

06 Blank (79)

filter

01 Blank (84)

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USDMF

Found USDMF

33973
Active
MONTELUKAST SODIUM USP
2019-08-13
CEP/COS

Found CEP/COS

R0-CEP 2019-211 - Rev 00
Valid
Montelukast sodium
2022-06-03
Japanese DMF

Found JDMF

303MF10148
Montelukast Sodium at No. 1, North ...
2021-09-17
Written Confirmation

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Application Number
33973
303MF10148
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
MONTELUKAST SODIUM USP
Montelukast sodium
Montelukast Sodium at No. 1, North ...
Issue/Submission Date
2019-08-13
2022-06-03
2021-09-17
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USDMF

Found USDMF

25714
Active
POTASSIUM CLAVULANATE, DILUTED WITH...
2012-01-16
CEP/COS

Found CEP/COS

R1-CEP 2011-376 - Rev 02
Valid
Potassium clavulanate, diluted, Wit...
2021-03-01
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25714
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
POTASSIUM CLAVULANATE, DILUTED WITH...
Potassium clavulanate, diluted, Wit...
Issue/Submission Date
2012-01-16
2021-03-01
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USDMF

Found USDMF

25718
Active
CLAVULANATE POTASSIUM
2012-01-16
CEP/COS

Found CEP/COS

R1-CEP 2011-374 - Rev 00
Valid
Potassium clavulanate
2017-12-15
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
25718
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
CLAVULANATE POTASSIUM
Potassium clavulanate
Issue/Submission Date
2012-01-16
2017-12-15
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USDMF

Found USDMF

18995
Active
ISOFLURANE (NON-STERILE BULK)
2005-11-28
CEP/COS

Found CEP/COS

R1-CEP 2010-078 - Rev 00
Valid
Isoflurane
2016-04-22
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
18995
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
ISOFLURANE (NON-STERILE BULK)
Isoflurane
Issue/Submission Date
2005-11-28
2016-04-22
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USDMF

Found USDMF

19425
Active
MOSAPRIDE CITRATE (NON-STERILE BULK...
2006-04-20
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF10119
Mosapride citrate hydrate T at No. ...
2022-08-10
Written Confirmation

Close WC

Application Number
19425
304MF10119
Status
Active
Fees Paid
N/A
 
Filing Details
MOSAPRIDE CITRATE (NON-STERILE BULK...
Mosapride citrate hydrate T at No. ...
Issue/Submission Date
2006-04-20
2022-08-10
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USDMF

Found USDMF

36615
Active
TEGAFUR
2021-12-20
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF10137
Tegafur at No. 1, North Outer Ring ...
2022-10-05
Written Confirmation

Close WC

Application Number
36615
304MF10137
Status
Active
Fees Paid
N/A
 
Filing Details
TEGAFUR
Tegafur at No. 1, North Outer Ring ...
Issue/Submission Date
2021-12-20
2022-10-05
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USDMF

Found USDMF

23847
Active
ZOLEDRONIC ACID
2010-05-20
CEP/COS

Found CEP/COS

R0-CEP 2021-177 - Rev 00
Valid
Zoledronic acid monohydrate
2022-08-26
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
23847
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
ZOLEDRONIC ACID
Zoledronic acid monohydrate
Issue/Submission Date
2010-05-20
2022-08-26
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USDMF

Caution USDMF

19677
Inactive
POTASSIUM CLAVULANATE, DILUTED, NON...
2006-06-16
CEP/COS

Found CEP/COS

R1-CEP 2011-375 - Rev 02
Valid
Potassium clavulanate, diluted, Wit...
2021-04-08
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
19677
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
POTASSIUM CLAVULANATE, DILUTED, NON...
Potassium clavulanate, diluted, Wit...
Issue/Submission Date
2006-06-16
2021-04-08
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USDMF

Caution USDMF

20816
Inactive
ISOSORBIDE MONONITRATE (NON-STERILE...
2007-08-24
CEP/COS

Found CEP/COS

R0-CEP 2020-153 - Rev 00
Valid
Isosorbide mononitrate, diluted, 70...
2022-05-11
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
20816
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
ISOSORBIDE MONONITRATE (NON-STERILE...
Isosorbide mononitrate, diluted, 70...
Issue/Submission Date
2007-08-24
2022-05-11
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USDMF

Caution USDMF

19091
Inactive
SEVOFLURANE (NON-STERILE BULK FORM)
2005-12-20
CEP/COS

Found CEP/COS

R1-CEP 2012-234 - Rev 00
Valid
Sevoflurane
2018-06-15
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
19091
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
SEVOFLURANE (NON-STERILE BULK FORM)
Sevoflurane
Issue/Submission Date
2005-12-20
2018-06-15
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